Clinical Trial Subject CRM Backend

Clinical Trial Subject CRM Backend Template
User, Study, Subject, Screening, Visit, and AdverseEvent Tracking

Q: How do clinical trial subject CRM practices keep intake quality high as volume grows?

It is a backend schema and API for trial operations: users, studies, subjects, screening records, visit schedules, subject notes, and adverse event logs.

Q: How should clinical trial subject CRM teams model clients, matters, and internal handoffs without ambiguity?

It includes User, Study, Subject, Screening, Visit, AdverseEvent, and SubjectNote, plus an ER diagram, API playground, and an AI Agent prompt.

Q: Can we integrate e-sign or document storage without fragmenting the clinical trial subject CRM record?

Back4app gives you managed database, auth, real-time queries, and flexible schema so you can track screening status, visit schedules, notes, and safety events without running your own backend.

Q: How do I query subjects and visits with Flutter?

Use the Subject and Visit classes to list screening status and upcoming visits, then render them in a coordinator dashboard with the Back4app SDK.

Q: How do I manage clinical trial subject CRM access with Next.js server actions?

Use a server action to create a Parse Object for Screening, Visit, or SubjectNote with subject pointers and site constraints, and validate the write in Cloud Code.

Q: Can React Native cache adverse events offline?

Yes. Enable Local Datastore and pin AdverseEvent results so safety reviewers can read recent entries and sync updates after reconnecting.

Q: How do I prevent unauthorized access to subject data?

In Cloud Code beforeSave for Subject, Screening, Visit, AdverseEvent, and SubjectNote, enforce site-based access checks and reject writes from unapproved users.

Q: What is the best way to show trial operations on Android?

Query Study, Subject, Visit, AdverseEvent, and SubjectNote classes to display site rosters, screening status, visit activity, and safety alerts in a native screen.

Q: How does the screening-to-visit flow work end-to-end?

A coordinator registers a Subject, creates a Screening record, updates the screeningStatus, schedules a Visit, writes a SubjectNote if needed, and logs any AdverseEvent tied to that visit.

A production-ready Clinical Trial Subject CRM backend on Back4app with Study, Subject, Screening, Visit, AdverseEvent, and SubjectNote workflows. Includes ER diagram, data dictionary, JSON schema, API playground, and an AI Agent prompt for rapid bootstrap.

Build with AI Agent Choose Your Technology

Trial Takeaways

This template gives you a Clinical Trial Subject CRM backend with User, Study, Subject, Screening, Visit, AdverseEvent, and SubjectNote classes so coordinators can run subject operations with less manual follow-up.

Screening status tracking — Model each Subject and Screening record so coordinators can see pending, passed, failed, or rescreen states with screeningDate and notes.
Visit schedule visibility — Use Visit.visitType, scheduledAt, visitStatus, location, and coordinator to keep planned visits and reschedules queryable.
Adverse event logging — Capture AdverseEvent.eventTerm, severity, serious, onsetDate, status, and reportedBy for safety review.
Coordinator-friendly workflow — Support study staff with Subject.coordinator assignments, Screening.completedBy, Visit.coordinator, and SubjectNote.author in one backend.
Cross-platform trial operations — Serve web, mobile, and clinical dashboards through one REST and GraphQL API for subjects, visits, safety notes, and adverse events.

What Is the Clinical Trial Subject CRM Template?

Reporting in clinical trial subject CRM should answer leadership questions without a manual hunt through folders and message threads. It is rarely a single bug — it is drift. Back4app anchors the core entities for clinical trial subject CRM practices that need deadlines, documents, and comms in one permissioned workspace. The schema covers User, Study, Subject, Screening, Visit, AdverseEvent, and SubjectNote records with auth and safety-aware workflows built in. Connect your preferred frontend and ship faster.

Best for:

Clinical trial operations appsSubject screening trackersVisit scheduling toolsAdverse event logging systemsClinical coordinator dashboardsTeams selecting BaaS for regulated workflows

Clinical Trial Subject CRM backend overview

clinical trial subject CRM teams win when routine work is boring: predictable records, obvious ownership, and alerts before small issues become incidents.

Review study assignment tracking, subject registry, screening workflow first, then open a stack card to see SDK-specific notes and integration patterns.

Clinical Trial Core Functions

Every technology card in this hub uses the same clinical trial backend schema with User, Study, Subject, Screening, Visit, AdverseEvent, and SubjectNote.

Study assignment tracking

Study stores protocolId, title, status, principalInvestigator, and siteName.

Subject registry

Subject stores subjectId, fullName, screeningStatus, study, coordinator, dob, sexAtBirth, and consentSignedAt.

Screening workflow

Screening links a subject, study, screeningStatus, screeningDate, completedBy, and notes.

Visit scheduling

Visit captures subject, study, visitType, scheduledAt, visitStatus, location, and coordinator.

Safety event logging

AdverseEvent stores subject, study, eventTerm, severity, serious, onsetDate, status, and reportedBy.

Why Build Your Clinical Trial Subject CRM Backend with Back4app?

Back4app gives you User, Study, Subject, Screening, Visit, AdverseEvent, and SubjectNote primitives so coordinators can focus on trial operations instead of wiring infrastructure.

•Screening and subject flow in one schema: The Subject and Screening classes keep subjectId, fullName, screeningStatus, screeningDate, and completedBy in one place.
•Visit schedules stay queryable: Visit and SubjectNote fields make planned appointments, reschedules, and staff follow-ups easy to review.
•Safety logging is explicit: AdverseEvent entries with eventTerm, severity, serious, onsetDate, status, and reportedBy support reviewable event timelines.

Build a clinical-trial backend that keeps screening, visits, notes, and adverse events aligned across teams.

Trial Benefits

A clinical trial backend that helps coordinators work faster while keeping subject operations structured.

Fast trial startup

Start from a complete User, Study, Subject, Screening, Visit, AdverseEvent, and SubjectNote schema instead of mapping trial tables from scratch.

Clear screening status

Use Subject.screeningStatus and Screening.screeningStatus to separate pending, passed, failed, and rescreen cases.

Visit coordination without guessing

Schedule and reschedule Visit records with visitType, scheduledAt, visitStatus, and location so staff know what comes next.

Safety review trail

AdverseEvent.severity, serious, onsetDate, status, and reportedBy give safety teams a readable event history.

Subject notes stay tied to the record

SubjectNote.noteType, noteText, author, and subject keep call, visit, and screening notes attached to the right participant.

AI-assisted bootstrap workflow

Generate backend scaffolding and integration guidance quickly with one structured prompt.

Ready to launch your Clinical Trial Subject CRM?

Let the Back4app AI Agent scaffold your Clinical Trial Subject CRM backend and generate User, Study, Subject, Screening, Visit, AdverseEvent, and SubjectNote workflows from one prompt.

Build with AI Agent Try the API Sandbox

Free to start — 50 AI Agent prompts/month, no credit card required

Clinical Trial Tech Stack

Everything included in this clinical trial backend template.

Frontend

13+ technologies

Backend

Back4app

Database

MongoDB

Auth

Built-in auth + sessions

API

REST and GraphQL

Realtime

Live Queries

Clinical Schema Map

Entity relationship model for the Clinical Trial Subject CRM backend schema.

ER Diagram

View diagram source

Mermaid

erDiagram
    User ||--o{ Study : "principalInvestigator"
    User ||--o{ Subject : "coordinator"
    User ||--o{ Screening : "completedBy"
    User ||--o{ Visit : "coordinator"
    User ||--o{ AdverseEvent : "reportedBy"
    User ||--o{ SubjectNote : "author"
    Study ||--o{ Subject : "study"
    Study ||--o{ Screening : "study"
    Study ||--o{ Visit : "study"
    Study ||--o{ AdverseEvent : "study"
    Subject ||--o{ Screening : "subject"
    Subject ||--o{ Visit : "subject"
    Subject ||--o{ AdverseEvent : "subject"
    Subject ||--o{ SubjectNote : "subject"

    User {
        String objectId PK
        String username
        String email
        String password
        String role
        String siteName
        Date createdAt
        Date updatedAt
    }

    Study {
        String objectId PK
        String protocolId
        String title
        String status
        String principalInvestigatorId FK
        String siteName
        Date createdAt
        Date updatedAt
    }

    Subject {
        String objectId PK
        String subjectId
        String fullName
        String screeningStatus
        String studyId FK
        String coordinatorId FK
        Date dob
        String sexAtBirth
        Date consentSignedAt
        Date createdAt
        Date updatedAt
    }

    Screening {
        String objectId PK
        String subjectId FK
        String studyId FK
        String screeningStatus
        Date screeningDate
        String completedById FK
        String notes
        Date createdAt
        Date updatedAt
    }

    Visit {
        String objectId PK
        String subjectId FK
        String studyId FK
        String visitType
        Date scheduledAt
        String visitStatus
        String location
        String coordinatorId FK
        Date createdAt
        Date updatedAt
    }

    AdverseEvent {
        String objectId PK
        String subjectId FK
        String studyId FK
        String eventTerm
        String severity
        Boolean serious
        Date onsetDate
        String status
        String reportedById FK
        Date createdAt
        Date updatedAt
    }

    SubjectNote {
        String objectId PK
        String subjectId FK
        String authorId FK
        String noteType
        String noteText
        Date createdAt
        Date updatedAt
    }

Clinical Integration Flow

Typical runtime flow for User sign-in, Subject screening, Visit scheduling, SubjectNote entry, and AdverseEvent logging.

ER Diagram

View diagram source

Mermaid

sequenceDiagram
  participant User
  participant App as Clinical Trial Subject CRM App
  participant Back4app as Back4app Cloud

  User->>App: Sign in
  App->>Back4app: POST /login
  Back4app-->>App: Session token

  User->>App: Open screening queue
  App->>Back4app: GET /classes/Screening?include=subject,study&order=-screeningDate
  Back4app-->>App: Screening rows with subjectId and screeningStatus

  User->>App: Add a visit schedule
  App->>Back4app: POST /classes/Visit
  Back4app-->>App: Visit objectId and scheduledAt

  User->>App: Log an adverse event
  App->>Back4app: POST /classes/AdverseEvent
  Back4app-->>App: AdverseEvent objectId and status

  App->>Back4app: Subscribe to live updates for Visit and AdverseEvent
  Back4app-->>App: Real-time subject activity

Field Guide

Full field-level reference for every class in the clinical trial schema.

Field	Type	Description	Required
objectId	String	Auto-generated unique identifier	Auto
username	String	User login name
email	String	User email address
password	String	Hashed password (write-only)
role	String	Role of the user, such as coordinator, investigator, or sponsor
siteName	String	Clinical site or clinic name	—
createdAt	Date	Auto-generated creation timestamp	Auto
updatedAt	Date	Auto-generated last-update timestamp	Auto

8 fields in User

Clinical Access Controls

How ACL and CLP strategy secures studies, subjects, visits, subject notes, and adverse event logs.

Coordinator-scoped access

Only approved trial staff can create or edit Subject, Screening, Visit, AdverseEvent, and SubjectNote records.

Site-level data separation

Use Study ownership and pointer-based queries so teams only see the subjects assigned to their site.

Safety log integrity

AdverseEvent entries should be write-restricted and validated in Cloud Code before they reach review.

JSON Schema

Raw JSON schema definition ready to copy into Back4app or use as implementation reference.

JSON

100

101

102

103

104

105

106

107

108

109

110

111

112

113

114

115

116

117

118

119

120

121

122

123

124

125

126

127

128

129

130

131

132

133

134

135

136

137

138

139

140

141

142

143

144

145

146

147

148

149

150

151

152

153

154

155

156

157

158

159

160

161

162

163

164

165

166

167

168

169

170

171

172

173

174

175

176

177

178

179

180

181

182

183

184

185

186

187

188

189

190

191

192

193

194

195

196

197

198

199

200

201

202

203

204

205

206

207

208

209

210

211

212

213

214

215

216

217

218

219

220

221

222

223

224

225

226

227

228

229

230

231

232

233

234

235

236

237

238

239

240

241

242

243

244

245

246

247

248

249

250

251

252

253

254

255

256

257

258

259

260

261

262

263

264

265

266

267

268

269

270

271

272

273

274

275

276

277

278

279

280

281

282

283

284

285

286

287

288

289

290

291

292

293

294

295

296

297

298

299

300

301

302

303

304

305

306

307

308

309

{
  "classes": [
    {
      "className": "User",
      "fields": {
        "objectId": {
          "type": "String",
          "required": false
        },
        "username": {
          "type": "String",
          "required": true
        },
        "email": {
          "type": "String",
          "required": true
        },
        "password": {
          "type": "String",
          "required": true
        },
        "role": {
          "type": "String",
          "required": true
        },
        "siteName": {
          "type": "String",
          "required": false
        },
        "createdAt": {
          "type": "Date",
          "required": false
        },
        "updatedAt": {
          "type": "Date",
          "required": false
        }
      }
    },
    {
      "className": "Study",
      "fields": {
        "objectId": {
          "type": "String",
          "required": false
        },
        "protocolId": {
          "type": "String",
          "required": true
        },
        "title": {
          "type": "String",
          "required": true
        },
        "status": {
          "type": "String",
          "required": true
        },
        "principalInvestigator": {
          "type": "Pointer",
          "required": true,
          "targetClass": "User"
        },
        "siteName": {
          "type": "String",
          "required": true
        },
        "createdAt": {
          "type": "Date",
          "required": false
        },
        "updatedAt": {
          "type": "Date",
          "required": false
        }
      }
    },
    {
      "className": "Subject",
      "fields": {
        "objectId": {
          "type": "String",
          "required": false
        },
        "subjectId": {
          "type": "String",
          "required": true
        },
        "fullName": {
          "type": "String",
          "required": true
        },
        "screeningStatus": {
          "type": "String",
          "required": true
        },
        "study": {
          "type": "Pointer",
          "required": true,
          "targetClass": "Study"
        },
        "coordinator": {
          "type": "Pointer",
          "required": true,
          "targetClass": "User"
        },
        "dob": {
          "type": "Date",
          "required": false
        },
        "sexAtBirth": {
          "type": "String",
          "required": false
        },
        "consentSignedAt": {
          "type": "Date",
          "required": false
        },
        "createdAt": {
          "type": "Date",
          "required": false
        },
        "updatedAt": {
          "type": "Date",
          "required": false
        }
      }
    },
    {
      "className": "Screening",
      "fields": {
        "objectId": {
          "type": "String",
          "required": false
        },
        "subject": {
          "type": "Pointer",
          "required": true,
          "targetClass": "Subject"
        },
        "study": {
          "type": "Pointer",
          "required": true,
          "targetClass": "Study"
        },
        "screeningStatus": {
          "type": "String",
          "required": true
        },
        "screeningDate": {
          "type": "Date",
          "required": true
        },
        "completedBy": {
          "type": "Pointer",
          "required": true,
          "targetClass": "User"
        },
        "notes": {
          "type": "String",
          "required": false
        },
        "createdAt": {
          "type": "Date",
          "required": false
        },
        "updatedAt": {
          "type": "Date",
          "required": false
        }
      }
    },
    {
      "className": "Visit",
      "fields": {
        "objectId": {
          "type": "String",
          "required": false
        },
        "subject": {
          "type": "Pointer",
          "required": true,
          "targetClass": "Subject"
        },
        "study": {
          "type": "Pointer",
          "required": true,
          "targetClass": "Study"
        },
        "visitType": {
          "type": "String",
          "required": true
        },
        "scheduledAt": {
          "type": "Date",
          "required": true
        },
        "visitStatus": {
          "type": "String",
          "required": true
        },
        "location": {
          "type": "String",
          "required": false
        },
        "coordinator": {
          "type": "Pointer",
          "required": true,
          "targetClass": "User"
        },
        "createdAt": {
          "type": "Date",
          "required": false
        },
        "updatedAt": {
          "type": "Date",
          "required": false
        }
      }
    },
    {
      "className": "AdverseEvent",
      "fields": {
        "objectId": {
          "type": "String",
          "required": false
        },
        "subject": {
          "type": "Pointer",
          "required": true,
          "targetClass": "Subject"
        },
        "study": {
          "type": "Pointer",
          "required": true,
          "targetClass": "Study"
        },
        "eventTerm": {
          "type": "String",
          "required": true
        },
        "severity": {
          "type": "String",
          "required": true
        },
        "serious": {
          "type": "Boolean",
          "required": true
        },
        "onsetDate": {
          "type": "Date",
          "required": true
        },
        "status": {
          "type": "String",
          "required": true
        },
        "reportedBy": {
          "type": "Pointer",
          "required": true,
          "targetClass": "User"
        },
        "createdAt": {
          "type": "Date",
          "required": false
        },
        "updatedAt": {
          "type": "Date",
          "required": false
        }
      }
    },
    {
      "className": "SubjectNote",
      "fields": {
        "objectId": {
          "type": "String",
          "required": false
        },
        "subject": {
          "type": "Pointer",
          "required": true,
          "targetClass": "Subject"
        },
        "author": {
          "type": "Pointer",
          "required": true,
          "targetClass": "User"
        },
        "noteType": {
          "type": "String",
          "required": true
        },
        "noteText": {
          "type": "String",
          "required": true
        },
        "createdAt": {
          "type": "Date",
          "required": false
        },
        "updatedAt": {
          "type": "Date",
          "required": false
        }
      }
    }
  ]
}

Build with AI Agent

Use the Back4app AI Agent to generate a real Clinical Trial Subject CRM app from this template, including frontend, backend, auth, and screening, visit, note, and safety flows.

Back4app AI Agent

Ready to build

Create a secure Clinical Trial Subject CRM backend on Back4app with this exact schema and behavior.

Schema:
1. User (use Back4app built-in): username, email, password, role, siteName; objectId, createdAt, updatedAt (system).
2. Study: protocolId (String, required), title (String, required), status (String, required), principalInvestigator (Pointer to User, required), siteName (String, required); objectId, createdAt, updatedAt (system).
3. Subject: subjectId (String, required), fullName (String, required), screeningStatus (String, required), study (Pointer to Study, required), coordinator (Pointer to User, required), dob, sexAtBirth, consentSignedAt; objectId, createdAt, updatedAt (system).
4. Screening: subject (Pointer to Subject, required), study (Pointer to Study, required), screeningStatus (String, required), screeningDate (Date, required), completedBy (Pointer to User, required), notes (String); objectId, createdAt, updatedAt (system).
5. Visit: subject (Pointer to Subject, required), study (Pointer to Study, required), visitType (String, required), scheduledAt (Date, required), visitStatus (String, required), location (String), coordinator (Pointer to User, required); objectId, createdAt, updatedAt (system).
6. AdverseEvent: subject (Pointer to Subject, required), study (Pointer to Study, required), eventTerm (String, required), severity (String, required), serious (Boolean, required), onsetDate (Date, required), status (String, required), reportedBy (Pointer to User, required); objectId, createdAt, updatedAt (system).
7. SubjectNote: subject (Pointer to Subject, required), author (Pointer to User, required), noteType (String, required), noteText (String, required); objectId, createdAt, updatedAt (system).

Security:
- Keep subject lists limited to authenticated staff.
- Let coordinators edit Subjects and Visits for their site.
- Restrict AdverseEvent entry to authenticated users with coordinator or investigator roles.
- Use ACLs and CLPs so screening status, visit schedules, subject notes, and adverse event logs are protected from public access.

Auth:
- Sign-up, login, logout.

Behavior:
- Track screening queue, subject assignment, visit schedules, adverse event logs, and subject notes.
- Support queries filtered by study, screeningStatus, visitStatus, and serious adverse events.

Deliver:
- Back4app app with schema, ACLs, CLPs; frontend for screening dashboards, visit planning, adverse event reporting, and subject notes.

Press the button below to open the Agent with this template prompt pre-filled.

This is the base prompt without a technology suffix. You can adapt the generated frontend stack afterward.

Deploy in minutes50 free prompts / monthNo credit card required

API Sandbox

Try REST and GraphQL endpoints against the clinical trial schema. Responses use mock data and do not require a Back4app account.

Loading playground…

Uses the same schema as this template.

Pick Your Stack

Expand each card to see how to integrate Study, Subject, and Screening with your chosen stack.

What You Get with Every Technology

Every stack uses the same clinical trial backend schema and API contracts.

Unified trial operations data structure

Easily manage User, Study, Subject, Screening, Visit, AdverseEvent, and SubjectNote records with a consistent schema.

Screening status control for trial teams

Track eligibility and enrollment milestones with explicit Subject fields.

Visit scheduling for coordinators

Coordinate scheduled, completed, missed, or canceled visits in one place.

Safety event logging for clinical workflows

Record adverse events with severity and follow-up status.

Clinical Stack Comparison

Compare setup speed, SDK style, and AI support across all supported technologies.

Framework	Setup Time	Clinical Trial Benefit	SDK Type	AI Support
Flutter	About 5 min	Single codebase for coordinator apps across mobile and web.	Typed SDK	Full
React	Under 5 minutes	Fast web dashboard for screening and visit planning.	Typed SDK	Full
React Native	~3–7 min	Cross-platform mobile app for site staff.	Typed SDK	Full
Next.js	Rapid (5 min) setup	Server-rendered clinical operations dashboard.	Typed SDK	Full
JavaScript	~3–5 min	Lightweight web integration for trial operations.	Typed SDK	Full
Android	About 5 min	Native Android app for coordinators.	Typed SDK	Full
iOS	Under 5 minutes	Native iOS app for visit and safety review.	Typed SDK	Full
Vue	~3–7 min	Reactive web UI for subject tracking.	Typed SDK	Full
Angular	Rapid (5 min) setup	Enterprise dashboard for clinical teams.	Typed SDK	Full
GraphQL	Under 2 min	Flexible GraphQL API for nested trial queries.	GraphQL API	Full
REST API	Quick (2 min) setup	REST API integration for clinical operations.	REST API	Full
PHP	~3 min	Server-side PHP integration for coordinator tools.	REST API	Full
.NET	~3–7 min	.NET backend for regulated workflow apps.	Typed SDK	Full

Setup time reflects expected duration from project bootstrap to first subject or visit query using this template schema.

Clinical Trial FAQs

Common questions about building a Clinical Trial Subject CRM backend with this template.

How do clinical trial subject CRM practices keep intake quality high as volume grows?

How should clinical trial subject CRM teams model clients, matters, and internal handoffs without ambiguity?

Can we integrate e-sign or document storage without fragmenting the clinical trial subject CRM record?

How do I query subjects and visits with Flutter?

How do I manage clinical trial subject CRM access with Next.js server actions?

Can React Native cache adverse events offline?

How do I prevent unauthorized access to subject data?

What is the best way to show trial operations on Android?

How does the screening-to-visit flow work end-to-end?

Trusted by developers worldwide

Join teams shipping Clinical Trial Subject CRM products faster with Back4app templates

Ready to Build Your Clinical Trial Subject CRM App?

Start your clinical trial project in minutes. No credit card required.

Choose Technology

Clinical Trial Subject CRM Backend TemplateUser, Study, Subject, Screening, Visit, and AdverseEvent Tracking